American Distilling Inc.
Form 483 issued April 26, 2022 · East Hampton, Connecticut
- Inspection
- Apr 18 – Apr 26, 2022
- Investigator
- Samir C. Gala
- Observations
- 4
- Pages
- 5
- FEI number
- 1218029
In short: On April 26, 2022, FDA issued a Form 483 with 4 observations to American Distilling Inc. in East Hampton, Connecticut (FEI 1218029) after an inspection that ran Apr 18 – Apr 26, 2022. The investigator was Samir C. Gala. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The written stability testing…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Samir C. Gala
10 documents · 2020–2024
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Connecticut.
The firmAmerican Distilling Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Distilling Inc.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected American Distilling Inc.?
Samir C. Gala is named on this Form 483, for the inspection of Apr 18 – Apr 26, 2022. Each investigator has a profile showing what they cite most.
When was American Distilling Inc. inspected by FDA?
The inspection ran Apr 18 – Apr 26, 2022, and the Form 483 is dated April 26, 2022.
How do I get the full Form 483 for American Distilling Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.